Ultrasound for the Detection of Oxaliplatin-Induced Peripheral Neuropathy
NCT ID: NCT03958747
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-12-17
2025-11-26
Brief Summary
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Detailed Description
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I. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.
Secondary Objective
I. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.
II. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients.
III. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients.
IV. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients.
Exploratory Objectives I. To assess activated mast cells in skin biopsies in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.
II. To assess serum inflammatory markers in oxaliplatin-induced peripheral neuropathy patients in relation to severity of symptoms and above findings.
III. Exploratory Cohort (Oxaliplatin-induced peripheral neuropathy, OIPN) Objectives
IV. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and OIPN patients
V. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and oxaliplatin-induced peripheral neuropathy patients
VI. To determine if the above changes in nerve cross-sectional area correlate with nerve conduction study changes in the same oxaliplatin-induced peripheral neuropathy patients
VII. To determine if the above changes in nerve cross-sectional area correlate with changes on a self-reported neuropathy scale (QLQ-CIPN20) in the same oxaliplatin-induced peripheral neuropathy patients
VIII. To determine if the above changes in nerve cross-sectional area correlate with intraepidermal nerve fiber density changes on skin biopsy in the same oxaliplatin-induced peripheral neuropathy patients
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ultrasound
Undergo peripheral nerve ultrasound
Ultrasound - Serial and Tibial Nerve
Participants will undergo a serial and tibial nerve ultrasound
Skin Biopsy
Two skin biopsies will be obtained as 4.0 mm punch biopsies at distal end of leg in sural nerve territory (10 cm above lateral malleolus) and from the thigh
Abbreviated Neurologic Exam
Exam to include strength assessment of the tibialis anterior and gastrocnemius and deep tendon reflex exam of the Achilles on the limb to be examined by nerve conduction velocity and ultrasound.
Blood draw
12 ml blood sample will be taken
Nerve Conduction Study
Sural and tibial nerve assessments
QLQ-CIPN20 Questionnaire Administration
Self-reported neuropathy scoring questionnaire completed same day as blood draw.
Interventions
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Ultrasound - Serial and Tibial Nerve
Participants will undergo a serial and tibial nerve ultrasound
Skin Biopsy
Two skin biopsies will be obtained as 4.0 mm punch biopsies at distal end of leg in sural nerve territory (10 cm above lateral malleolus) and from the thigh
Abbreviated Neurologic Exam
Exam to include strength assessment of the tibialis anterior and gastrocnemius and deep tendon reflex exam of the Achilles on the limb to be examined by nerve conduction velocity and ultrasound.
Blood draw
12 ml blood sample will be taken
Nerve Conduction Study
Sural and tibial nerve assessments
QLQ-CIPN20 Questionnaire Administration
Self-reported neuropathy scoring questionnaire completed same day as blood draw.
Eligibility Criteria
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Inclusion Criteria
* Colorectal cancer (any stage)
* Previously or currently receiving oxaliplatin -based chemotherapy.
* Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to oxaliplatin -based therapy.
* Ability and willingness to understand and sign an informed consent.
Exclusion Criteria
* Unable to provide history.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Roy Strowd, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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WFBCCC 97219
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00059662
Identifier Type: -
Identifier Source: org_study_id